This study is accepting new patients by invitation only

Open-Label Extension Study of Setmelanotide

a study on Obesity

Summary

Eligibility
for people ages 2 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.

Official Title

Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway

Keywords

Obesity Associated With Defects in Leptin-melanocortin Pathway, setmelanotide, RM-493, obesity, melanocortin 4 receptor, hypothalamic obesity, Setelanotide (Open-label)

Eligibility

You can join if…

Open to people ages 2 years and up

  • Males and females ≥2 years of age who have completed a previous setmelanotide clinical study and who have a condition or indication for which Rhythm plans further clinical development.
  • Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after.
  • Demonstrated clinical benefit in the previous setmelanotide study, as determined by the Investigator.

You CAN'T join if...

  • Any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the United States (i.e., patients eligible for commercial setmelanotide (IMCIVREE®).
  • Any new or worsening depression resulting in suicidal thoughts and/or behaviors.
  • Discontinuation from a previous setmelanotide study.
  • History or close family history (parents or siblings) of melanoma.
  • Pregnant and/or breastfeeding women

Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UC San Diego- Rady Children's Hospital
    San Diego California 92123 United States
  • HonorHealth Research Institute
    Scottsdale Arizona 85258 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Rhythm Pharmaceuticals, Inc.
ID
NCT06596135
Phase
Phase 3 Obesity Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated